Employer requires a Masters degree in Biomedical Engineering, Biomedical Technology, Engineering Management or related technical field plus 12 months of experience in job Offered, Quality Engineer I, Quality Engineer II or related occupation. Experience must include 1 Design Controls, 2 Risk Management Hazard Analysis, Task Analysis, Design FMEA, Risk Management PlanReport, Process Risk Analysis, 3 Usability Testing, 4 Product Sustaining activities Design Changes, NonConformance Reports, Root Cause Analysis, CAPAs, Equipment out of Calibration Reports, Revalidation Assessments, 5 Test Method ValidationsGage RRs, 6 Development of User Needs and Product Specifications, 7 Verification and Validation activities Design Verification, Design Validation, Process Validation, 8 InspectionTesting Techniques Optical Measurement systems, Calipers, Micrometers, RingPin Gauges, HeightDrop Gauges, Instron tests, visual inspection methods, 9 Statistical Techniques Verification Validation Sampling Plans, Hypothesis testing, Process Capability Indices, ANOVA, and 10 Software PLM system Windchill and Statistical Software Minitab.
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